A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: placebo; Drug: Aricept (donepezil hydrochloride)

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
      • Neurology Neurodiagnostic Lab, LLC
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
    • Sun City, Arizona, United States, 85351
      • Sun Health Research Institute
    • Tucson, Arizona, United States, 85741-3537
      • Northwest NeuroSpecialists, PLLC
  • California
    • Encinitas, California, United States, 92024
      • The Neurology Center
    • Fresno, California, United States, 93720
      • Margolin Brain Institute
    • Garden Grove, California, United States, 92845
      • Colaborative Neuroscience Network (CNS Network)
    • Irvine, California, United States, 92618
      • Nerve Pro Research
    • La Mesa, California, United States, 91942
      • Optimum Health Services
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Sherman Oaks, California, United States, 91403
      • CA Neuroscience Research
    • Vista, California, United States, 92081
      • Pacific Research Network
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • North Broward Medical Center Memory Disorder Center
    • Ft. Lauderdale, Florida, United States, 33308
      • Neurologic Consultants
    • Hialeah, Florida, United States, 33016
      • Berma Research Group
    • Hollywood, Florida, United States, 33021
      • Sunrise Clinical Research
    • Miami Beach, Florida, United States, 33140
      • Wien Center for Memory Disorders, Mount Sinai Medical Center
    • Plantation, Florida, United States, 33317
      • Berma Research Group
    • Sarasota, Florida, United States, 34243
      • The Roskamp Institute
    • St. Petersburg, Florida, United States, 33702
      • Comprehensive NeuroScience, Inc.
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
    • Tampa, Florida, United States, 33613
      • USF Memory Disorder's Clinic
    • Tampa, Florida, United States, 33617
      • USF Suncoast Gerontalogy Center
    • Venice, Florida, United States, 34285
      • Center for Clinical Trials. L.C.
    • West Palm Beach, Florida, United States, 33407
      • Palm Beach Neurology
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Lexington Clinic
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • St. Louis University - Clinical Trials Unit
  • New Jersey
    • Kenilworth, New Jersey, United States, 07033
      • Comprehensive NeuroScience, Inc
  • New York
    • Albany, New York, United States, 12208
      • Neurological Associates of Albany, PC Neurology
    • Lawrence, New York, United States, 11559
      • Neurobehavioral Research Inc.
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10016
      • New York University School of Medicine Aging and Dementia Research Center
    • Rochester, New York, United States, 14620
      • Monroe Community Hospital Program in Neurobehavioral Therapeutics
    • Staten Island, New York, United States, 10305
      • Behavioral Medical Research Of Staten Island
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Toledo, Ohio, United States, 43623
      • Neurology Center Of Ohio
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Pahl Pharmaceutical Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network(Oregon) Inc.
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
      • Clinical Trial Specialists
    • Greensburg, Pennsylvania, United States, 15601
      • Westmoreland Neurology Associates
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina-Alzheimer's Research
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Mental Sciences Instittute
    • San Antonio, Texas, United States, 78229-3900
      • START Center
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Southwestern Vermont Medical Center - The Memory Clinc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age Range: Adult subjects (45 to 90 years of age inclusive)
2. Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]
3. Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
4. A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
5. Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
6. The subject must be expected to complete the entire study.
7. Subjects must be sufficiently fluent in English.
8. Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.
9. Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).

Exclusion Criteria:

1. Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
2. Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
3. Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
4. Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
5. Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.
6. Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
7. Subjects who may not be able to comply with the protocol.
8. Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
9. Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.
10. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
11. Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Aricept (donepezil hydrochloride); 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.; Other Names: donepezil hydrochloride
Placebo Comparator: 2	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events	Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)	Baseline, Week 6, Week 12 and Week 28.

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Anita Murthy, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: May 14, 2009
• First Submitted That Met QC Criteria: May 14, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: E2020-A001-414